Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD)

NCT00518570 | Completed

• 2 other identifiers: Levetiracetam and PMDDBMC03-010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.

Conditions

Premenstrual Dysphoric Disorder

Keywords

PMDD; PMS; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• Daily Record of Severity of Problems (DRSP), Clinical Global Impression- Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I).

  4 months

Secondary Outcomes (1)

• How Levetiracetam is tolerated, adverse events.

  4 months

Study Arms (1)

Open-Label treatment

EXPERIMENTAL

Patients prospectively diagnosed with premenstrual dysphoric disorder.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months.

Also known as: Keppra

Open-Label treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PMDD diagnostic and severity criteria:
• Women with PMDD according to DSM-IV-TR criteria
• At screening by history
• At the end of the Qualification Phase by review of symptom records.
• The first 2 consecutive or 2 out of 3 consecutive qualification cycles must fulfill the following criteria:
• For women who were not on any medications for the PMDD symptoms:
• Late luteal phase (6 days before menses through day 1) daily average at least twice as high as follicular phase daily average for five distinct items.
• Functional impairment questions for late luteal phase require more than or equal to 4 score on at least one item for at least 2 or more days.
• For women who were on anti-depressants or oral contraceptive for at least 2 months:
• Late luteal phase (6 days before menses through day 1 of menses) daily average at least twice as high as follicular phase daily average for three distinct items.
• Functional impairment questions for late luteal phase require 3 or more score on at least one item for 2 or more days.
• Absence of any one of the following Axis I disorders during the last 6 months:
• Major Depressive Disorder
• Anxiety Disorder (Panic Disorder, OCD, PTSD)
• Eating Disorder

You may not qualify if:

• Women, who are pregnant, gave birth within the last 8 months, breast-feeding or intending to become pregnant within 6 months.
• Contraindication or hypersensitivity to levetiracetam.
• Ongoing psychotherapy, which has begun \<3months prior to the study visit.
• Participation in another clinical trial within the last 3 months prior to the screening visit.
• Known hypersensitivity to Levetiracetam
• Any disease or condition that can compromise the function of body systems and which could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
• Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.
• Uncontrolled thyroid problems.
• Active use of substances, excluding caffeine and nicotine, will not be permitted during the study.

Sponsors & Collaborators

• Berkshire Health Systems: lead
• UCB Pharma: collaborator

Study Sites (1)

Berkshire Medical Center, Clinical Trials Program, Department of Psychiatry

Pittsfield, Massachusetts, 01201, United States

Location

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zerrin E Kayatekin, MD

  Berkshire Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 20, 2007
• Study Start: November 1, 2003
• Study Completion: October 1, 2006
• Last Updated: August 20, 2007

Record last verified: 2007-08

Locations

US (1)